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Atrial fibrillation causes a fivefold increase of stroke risk. CHA 2 DS 2 -VAS C is widely used to evaluate the risk of cardiac embolism in patients with non-valvular atrial fibrillation (NVAF) and identify the patients eligible for anticoagulation therapy. This study aimed to identify the significance of CHA 2 DS 2 -VAS C score on the severity and hemorrhagic transformation (HT) in patients with NVAF-induced acute ischemic stroke (NVAF-AIS). Total 113 patients diagnosed as NVAF-AIS were included in this study. Patients were categorized into severe stroke group (NIHSS > 10) and non-severe group (NIHSS ≤ 10), and the risk factors for severe stroke were investigated. Based on the results of repeated brain CT/MRI examination performed within 14 days from stroke onset or immediately in case of clinical worsening, patients were divided into HT group and non-HT group, and the predictors for HT were then analyzed. CHA 2 DS 2 -VAS C score [median (interquartile range) 5 (3-5) vs. 3 (2-4); p = 0.002] in severe stroke group was significantly higher than that in non-severe group. The severe stroke group showed significantly increased prevalence of heart failure (20% vs. 48.5%, p = 0.002) and decreased hemoglobin (136.4 ± 18.0 vs.143.6 ± 15.6 g/L, p = 0.031) compared with non-severe group. Multivariate regression analysis revealed that CHA 2 DS 2 -VASc score was a powerful predictor for the severity of NVAF-AIS. Forty-seven of total recruited patients (43.2%) developed HT within 14 days after the onset of NVAF-AIS. CHA 2 DS 2 -VASc score as well as elevated glycated hemoglobin and intravenous rt-PA were the independent risk factors of HT. CHA 2 DS 2 -VAS C score was closely associated with the severity of NVAF-AIS. Patients with higher CHA 2 DS 2 -VAS C score were more likely to develop HT after NVAF-AIS., (© 2021. Società Italiana di Medicina Interna (SIMI).)

Purpose: Despite the large number of osteoporosis patients in China, the diagnosis and treatment rates remain low. The Fracture Risk Assessment Tool (FRAX) can be used to effectively evaluate fracture risk. In this study, we explored the Chinese-specific thresholds of FRAX without the T-score., Methods: In all, 264 postmenopausal women aged > 50 years were randomly recruited from community-medical centers. All subjects completed self-reported questionnaires, BMD measurements, and spinal radiographs. The 10-year hip and major osteoporotic fracture risks were calculated by FRAX. A new threshold for both 10-year hip and major osteoporotic fracture risk was explored with receiver operating characteristic (ROC) curve analysis., Results: Overall, 92 subjects were diagnosed with osteoporosis. Among them, 14 participants with T-score > - 2.5 were diagnosed with osteoporosis based on clinical fractures. ROC analysis showed the cut-off value of the 10-year hip osteoporotic fracture for detecting osteoporosis was 0.95%, while that of 10-year major osteoporotic fracture was 4.95%. The sensitivity and specificity of the 10-year hip osteoporotic fracture probability for detecting osteoporosis were 0.86 and 0.59, respectively, while the guideline-recommended threshold had a sensitivity of 0.49 and specificity of 0.83. The sensitivity and specificity of the 10-year major osteoporotic fractures with the new threshold were 0.76 and 0.69, respectively, while the recommended threshold had a sensitivity of 0 and specificity of 1., Conclusion: Current guideline-recommended FRAX thresholds without BMD showed low sensitivity. Therefore, 10-year osteoporotic hip fracture probability ≥ 0.95% and 10-year osteoporotic major fracture probability ≥ 4.95% are recommended as the new thresholds.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19 disease. There are concerns regarding limited testing capacity and the exclusion of cases from unproven screening criteria. Knowing COVID-19 risks can inform testing. This study derived and assessed a model to predict risk of SARS-CoV-2 in community-based people., Methods: All people presenting to a community-based COVID-19 screening center answered questions regarding symptoms, possible exposure, travel, and occupation. These data were anonymously linked to SARS-CoV-2 testing results. Logistic regression was used to derive a model to predict SARS-CoV-2 infection. Bootstrap sampling evaluated the model., Results: A total of 9172 consecutive people were studied. Overall infection rate was 6.2% but this varied during the study period. SARS-CoV-2 infection likelihood was primarily influenced by contact with a COVID-19 case, fever symptoms, and recent case detection rates. Internal validation found that the SARS-CoV-2 Risk Prediction Score (SCRiPS) performed well with good discrimination (c-statistic 0.736, 95%CI 0.715-0.757) and very good calibration (integrated calibration index 0.0083, 95%CI 0.0048-0.0131). Focusing testing on people whose expected SARS-CoV-2 risk equaled or exceeded the recent case detection rate would increase the number of identified SARS-CoV-2 cases by 63.1% (95%CI 54.5-72.3)., Conclusion: The SCRiPS model accurately estimates the risk of SARS-CoV-2 infection in community-based people undergoing testing. Using SCRiPS can importantly increase SARS-CoV-2 infection identification when testing capacity is limited.

Parents play a critical role in the early identification of ASD because of their experiential knowledge and frequent observations of their children. Being knowledgeable about ASD may help parents recognize early signs and symptoms, know to which professionals to express their concerns, and better navigate systems of care. An appropriate measure of ASD knowledge for parents is essential to further understand the importance of ASD knowledge in this population. This study sought to validate the Autism Spectrum Knowledge Scale-General Population Version (ASKSG) with a sample of parents with children under the age of 18 years in the United States. Results indicate that the ASKSG is a valid and reliable measure for use with parents.

The epidemic phase of Coronavirus disease 2019 (COVID-19) made the Worldwide health system struggle against a severe interstitial pneumonia requiring high-intensity care settings for respiratory failure. A rationalisation of resources and a specific treatment path were necessary. The study suggests a predictive model drawing on clinical data gathered by 119 consecutive patients with laboratory-confirmed COVID-19 admitted in Busto Arsizio hospital. We derived a score that identifies the risk of clinical evolution and in-hospital mortality clustering patients into four groups. The study outcomes have been compared across the derivation and validation samples. The prediction rule is based on eight simple patient characteristics that were independently associated with study outcomes. It is able to stratify COVID-19 patients into four severity classes, with in-hospital mortality rates of 0% in group 1, 6-12.5% in group 2, 7-20% in group 3 and 60-86% in group 4 across the derivation and validation sample. The prediction model derived in this study identifies COVID-19 patients with low risk of in-hospital mortality and ICU admission. The prediction model that the study presents identifies COVID-19 patients with low risk of in-hospital mortality and admission to ICU. Moreover, it establishes an intermediate portion of patients that should be treated accurately in order to avoid an unfavourable clinical evolution. A further validation of the model is important before its implementation as a decision-making tool to guide the initial management of patients.

Atrial fibrillation is the most common arrhythmia and its prevalence is expected to further increase. Patients with atrial fibrillation have an increased risk of stroke (fivefold increased risk), heart failure, and death. In patients with non-valvular atrial fibrillation, the most recent guidelines recommend the use of the CHA 2 DS 2 -VASc (congestive heart failure, arterial hypertension, age > 75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65-74 years, sex category) scoring system to identify those who may benefit from oral anticoagulant treatment. Guidelines recommend initiation of oral anticoagulation with vitamin K antagonists or direct oral anticoagulants in men with a score ≥ 2 and in women with a score ≥ 3, while oral anticoagulation in individuals with a score of 0 is not recommended. Accordingly, men with CHA 2 DS 2 VASc score = 1 (and women with CHA 2 DS 2 VASc = 2) represent a grey zone where guidelines do not provide a definite oral anticoagulant indication. Implementation of risk stratification with transthoracic echocardiography could be extremely useful. Both prospective and observational studies using transthoracic echocardiography prediction of events and studies utilizing transesophageal echocardiographic parameters as surrogate markers of thromboembolic events make sustainable the hypothesis that echocardiography could improve thromboembolism prediction in non-valvular atrial fibrillation. However, because of some controversial results of different studies, determination of the best echocardiographic parameter predicting thromboembolic events in atrial fibrillation remains uncertain. The combination of left atrial enlargement with left atrial function (in particular assessing left atrial strain) appears to be very valuable, but needs to be confirmed in large-scale multi-center trials.

Background: The Tyrer-Cuzick model has been shown to overestimate risk in women with atypical hyperplasia, although its accuracy among women with lobular carcinoma in situ (LCIS) is unknown. We evaluated the accuracy of the Tyrer-Cuzick model for predicting invasive breast cancer (IBC) development among women with LCIS., Methods: Women with LCIS participating in surveillance from 1987 to 2017 were identified from a prospectively maintained database. Tyrer-Cuzick score (version 7) was calculated near the time of LCIS diagnosis. Patients with prior or concurrent breast cancer, a BRCA mutation, receiving chemoprevention, or with pleomorphic LCIS were excluded. Invasive cancer-free probability was estimated using the Kaplan-Meier method., Results: A total of 1192 women with a median follow-up of 6 years (interquartile range [IQR] 2.5-9.9) were included. Median age at LCIS diagnosis was 49 years (IQR 45-55), 88% were white; 37% were postmenopausal, 28% had ≥ 1 first-degree family member with breast cancer, and 13% had ≥ 2 second-degree family members with breast cancer. In total, 128 patients developed an IBC; median age at diagnosis was 54 years (IQR 49-61). Five- and 10-year cumulative incidences of invasive cancer were 8% (95% confidence interval [CI] 6-9%) and 14% (95% CI 12-17%), respectively. The median Tyrer-Cuzick 10-year risk score was 20.1 (IQR 17.4-24.3). Discrimination measured by the C-index was 0.493, confirming that the Tyrer-Cuzick model is not well calibrated in this patient population., Conclusions: The Tyrer-Cuzick model is not accurate and may overpredict IBC risk for women with LCIS, and therefore should not be used for breast cancer risk assessment in this high-risk population.

We studied whether previously developed cardiac risk scores-including history, ECG, age, risk factors, and troponin (HEART); Thrombolysis in Myocardial Infarction (TIMI); Global Registry of Acute Coronary Events (GRACE); and Emergency Department Assessment of Chest Pain (EDACS)-could be applied to predict major adverse cardiac events (MACE) in patients with possible coronary artery disease, including anginal equivalents. Patients with chest pain or anginal equivalents who underwent coronary computed tomographic angiography were included. The primary outcome was 30-day MACE. We compared the cardiac risk scores by the area under the receiver-operating characteristic curves (AUC). The primary outcome occurred in 200 patients (16.0%) of the 1247 patients included. For the prediction of MACE, the AUC of the HEART score (0.765) was superior to those of the TIMI (0.726), GRACE (0.612), and EDACS (0.631) scores. Among patients identified by each score as being at low risk, the MACE rate was the lowest for the HEART score (5.7%), followed by the TIMI (8.8%), EDACS (11.2%), and GRACE (12.2%) scores. At a sensitivity level of a < 2% rate of misses, the negative predictive value of the HEART score (1.0) outperformed those of the GRACE (0.932) and EDACS (0.964). The HEART score appeared to be more predictive of MACEs than the TIMI, GRACE, and EDACS in patients with chest pain or anginal equivalents. However, previously suggested cutoff could not safely identify low-risk patients for early discharge because of the unacceptably high rate of missed MACEs.

Recent national guidelines recommend genetic risk assessment for all patients diagnosed with pancreatic cancer, yet individuals with pancreatic cancer obtain genetic testing at suboptimal rates. Both patient and provider factors play a role in adherence to genetic testing recommendations. The purpose of this study was to understand health care provider perspectives of caring for patients with inherited pancreatic cancer risk. The study was a cross-sectional mixed method study utilizing a qualitative interview and a survey. The study sample included health care providers who provide care for patients with pancreatic cancer or inherited risk. Qualitative data were analyzed using content analysis, while quantitative data were summarized using descriptive statistics. Thirty participants had complete interview data and 29 completed a survey. The sample was comprised of physicians (n = 17), genetic counselors (n = 6), nurses (n = 3), and social workers (n = 3). Respondents were less confident in their ability to identify patients with inherited pancreatic cancer risk compared with other hereditary cancer syndromes. Several challenges were identified including the pancreatic cancer illness trajectory; lack of evidence-based practice guidelines; difficulty interpreting genetic test results; and difficulty following up on referrals. Participants perceived a lack of educational resources for patients with inherited pancreatic cancer risk. Health care providers who care for individuals with inherited pancreatic cancer risk face challenges that are distinct from those encountered during the care of individuals for other hereditary cancers. There is a need for additional resources at the patient-, provider-, and system-level.

Background: Risk stratification of older patients in the emergency department (ED) is seen as a promising and efficient solution for handling the increase in demand for geriatric emergency medicine. Previously, the predictive validity of commonly used tools for risk stratification, such as the identification of seniors at risk (ISAR), have found only limited evidence in German geriatric patient samples. Given that the adverse outcomes in question, such as rehospitalization, nursing home admission and mortality, are substantially associated with cognitive impairment, the potential of the short portable mental status questionnaire (SPMSQ) as a tool for risk stratification of older ED patients was investigated., Objective: To estimate the predictive validity of the SPMSQ for a composite endpoint of adverse events (e.g. rehospitalization, nursing home admission and mortality)., Method: This was a prospective cohort study with 260 patients aged 70 years and above, recruited in a cardiology ED. Patients with a likely life-expectancy below 24 h were excluded. Follow-up examinations were conducted at 1, 3, 6 and 12 month(s) after recruitment., Results: The SPMSQ was found to be a significant predictor of adverse outcomes not at 1 month (area under the curve, AUC 0.55, 95% confidence interval, CI 0.46-0.63) but at 3 months (AUC 0.61, 95% CI 0.54-0.68), 6 months (AUC 0.63, 95% CI 0.56-0.70) and 12 months (AUC 0.63, 95% CI 0.56-0.70) after initial contact., Conclusion: For longer periods of observation the SPMSQ can be a predictor of a composite endpoint of adverse outcomes even when controlled for a range of confounders. Its characteristics, specifically the low sensitivity, make it unsuitable as an accurate risk stratification tool on its own.

Typical recreational water risk to swimmers is assessed using epidemiologically derived correlations by means of fecal indicator bacteria (FIB). It has been documented that concentrations of FIB do not necessarily correlate well with protozoa and viral pathogens, which pose an actual threat of illness and thus sometimes may not adequately assess the overall microbial risks from water resources. Many of the known pathogens have dose-response relationships; however, measuring water quality for all possible pathogens is impossible. In consideration of a typical freshwater receiving secondarily treated effluent, we investigated the level of consistency between the indicator-derived correlations and the sum of risks from six reference pathogens using a quantitative microbial risk assessment (QMRA) approach. Enterococci and E. coli were selected as the benchmark FIBs, and norovirus, human adenovirus (HAdV), Campylobacter jejuni, Salmonella enterica, Cryptosporidium spp., and Giardia spp. were selected as the reference pathogens. Microbial decay rates in freshwater and uncertainties in exposure relationships were considered in developing our analysis. Based on our exploratory assessment, the total risk was found within the range of risk estimated by the indicator organisms, with viral pathogens as dominant risk agents, followed by protozoan and bacterial pathogens. The risk evaluated in this study captured the likelihood of gastrointestinal illnesses only, and did not address the overall health risk potential of recreational waters with respect to other disease endpoints. Since other highly infectious pathogens like hepatitis A and Legionella spp. were not included in our analysis, these estimates should be interpreted with caution.

The usage of FRAX® tool in Thailand and other countries was explored using Google Analytics data. Over the period 2010-2018, Thailand ranked 35th in the world for FRAX usage (the US is ranked first). Incorporation of FRAX into a national osteoporosis guideline in Thailand appears to have increased its usage., Purpose: To document access to the web-based FRAX® tool and specifically its access in Thailand between 2010 and 2018., Methods: A descriptive retrospective study using data from Google Analytics that provides numerical and geographical information on internet access to the FRAX tool website worldwide., Result: In Thailand, Bangkok is the highest ranked site for FRAX access with more than 20,000 usage sessions since 2010 (3.6 usage session per 1000 population) followed by Khon Kaen and Chiang Mai. It has been accessed from within 76 out of 77 provinces (98.7%). There was a steady increase in access to FRAX from within Thailand of approximately 1000 usage sessions per year between 2010 and 2016. After the FRAX fracture risk calculation was included in the national guideline for osteoporosis management published in late 2016, the rate of increase in access was four-fold higher compared with the previous period. In world ranking, the USA is the country with the most frequent access to the FRAX tool, whereas Thailand was ranked 35th in the world. There were weak but significant correlations between the absolute number of FRAX sessions and population size (r = 0.165, p = 0.011) and land area (r = 0.375, p < 0.001)., Conclusion: Access to the FRAX tool website is increasing in Thailand. The incorporation of FRAX into national guidelines, in parallel to the adoption of osteoporosis fracture prevention into national policy, has had a rapid and significant impact on its use.

This study explores the use of the CHA 2 DS 2 -VASc and the AHEAD scores to predict incident dementia in patients with heart failure (HF) who need hospitalization. We used a large national database to study 387,595 adult patients hospitalized for HF from Taiwan. This registration cohort was followed to document the cumulative incidence of dementia. The area under the curve of receiver operating characteristics (AUROC) was used to evaluate the discriminative ability of CHA 2 DS 2 -VASc and AHEAD scores in predicting dementia, whereas the DeLong test was used to examine the difference between the predictive capacity. A higher CHA 2 DS 2 -VASc and AHEAD scores appear to be more strongly associated with a higher incidence of dementia. The AUROC for CHA 2 DS 2 -VASc score in predicting dementia (0.61, 95% CI = 0.60-0.61) is significantly higher than the AHEAD score (0.55, 95% CI = 0.54-0.55) (DeLong test p < 0.001). A significantly higher ability, by AUROC, of CHA 2 DS 2 -VASc score to predict new-onset dementia in patients hospitalized for HF is found.

We report the updated guidelines for the management of osteoporosis in Greece, which include guidance on fracture risk assessment, diagnosis-pharmacological treatment-follow-up of osteoporosis based on updated information, and national evidence from Greek clinical practice and the healthcare setting., Purpose: The purpose of this report was to update the Guidelines for the Management of Osteoporosis in Greece that was published in 2011., Methods: In line with the GRADE system, the working group initially defined the main clinical questions that should be addressed when dealing with the diagnosis and management of osteoporosis in clinical practice in Greece. Following a literature review and discussion on the experience gained from the implementation of the 2011 Guidelines transmitted through the national electronic prescription network, the Hellenic Society for the Study of Bone Metabolism (HSSBM) uploaded an initial draft for an open dialogue with the relevant registered medical societies and associations on the electronic platform of the Greek Ministry of Health. After revisions, the Central Health Council approved the final document., Results: The 2018 Guidelines provide comprehensive recommendations on the issues of the timing of fracture risk evaluation and dual-energy X-ray absorptiometry (DXA) measurement, interpretation of the DXA results, the diagnostic work-up for osteoporosis, the timing as well as the suggested medications for osteoporosis treatment, and the follow-up methodology employed during osteoporosis treatment., Conclusions: These updated guidelines were designed to offer valid guidance on fracture risk assessment, diagnosis-pharmacological treatment-follow-up of osteoporosis based on updated information and national evidence from clinical practice and the healthcare setting. Clinical judgment is essential in the management of every individual patient for the purpose of achieving the optimal outcome in the safest possible way.

This paper revised the fixed intervention thresholds (ITs) based on the Sri Lankan fracture risk assessment tool (FRAX) published in 2013 and introduced new ITs, hybrid and two-tier, aiming to help clinicians in the management of postmenopausal osteoporosis. The hybrid and two-tier ITs have a better discriminatory power than age-dependent and revised fixed ITs., Introduction: This study revised the Sri Lankan FRAX®-based intervention thresholds (ITs) previously published in 2013., Method: Age-dependent ITs were estimated, from 50-80 years with 5-year intervals, using a Sri Lankan FRAX® algorithm for a woman with a BMI of 24.8 kg/m 2 and history of prior fragility fracture without other clinical risk factors. Data of 653 postmenopausal women were used in estimating fixed, hybrid, and two-tier ITs. ITs were determined using the ROC curve and partial Youden index. New ITs were validated using data of 356 postmenopausal women who underwent DXA and 62 women who had a recent fragility fracture. Women in the two groups (n = 653 and n = 356) came from the Southern Province and had undergone DXA in our state-owned tertiary care hospital as a part of their routine clinical assessment., Results: The mean (SD) age and BMI of the subjects (n = 653) were 62 (8) years and 24.8 (1.2) kg/m 2 , respectively. Age-dependent ITs of major osteoporotic fracture risk (MOFR) and hip fracture risk (HFR) ranged from 2.7 to 18% and from 0.4 to 7.1%. The best fixed ITs for women aged 50-80 years were 9% for MOFR and 3% for HFR. In the hybrid method, MOFR of 6% and HFR of 2% were found appropriate for women aged < 70 years. These were combined with age-dependent ITs for women aged 70 years and above. In the two-tier system, two sets of ITs were calculated (ITs of MOFR/HFR for women aged < 70 years and ≥ 70 years were 6%/2% and 12%/5%, respectively). When age-dependent ITs were considered the reference standard, sensitivities of the fixed, hybrid, and two-tier ITs were 0.63, 0.73, and 0.74, respectively. The specificities were 0.76, 0.86, and 0.80 in the same order. Sensitivities of the age-dependent, fixed, hybrid, and two-tier ITs in identifying a woman with an incident fracture were 26%, 48%, 61%, and 61%, respectively., Conclusions: The new fixed MOFR is slightly lower than the previous value and hybrid and two-tier ITs perform better than age-dependent and fixed ITs.

Emergency departments are characterized by the need for quick diagnosis under pressure. To select the most appropriate treatment, a series of rules to support decision-making has been offered by scientific societies. The effectiveness of these rules affects the appropriateness of treatment and the hospitalization of patients. Analyzing a sample of 1844 patients and focusing on the decision to hospitalize a patient after a syncope event to prevent severe short-term outcomes, this work proposes a new algorithm based on neural networks. Artificial neural networks are a non-parametric technique with the well-known ability to generalize behaviors, and they can thus predict severe short-term outcomes with pre-selected levels of sensitivity and specificity. This innovative technique can outperform the traditional models, since it does not require a specific functional form, i.e., the data are not supposed to be distributed following a specific design. Based on our results, the innovative model can predict hospitalization with a sensitivity of 100% and a specificity of 79%, significantly increasing the appropriateness of medical treatment and, as a result, hospital efficiency. According to Garson's Indexes, the most significant variables are exertion, the absence of symptoms, and the patient's gender. On the contrary, cardio-vascular history, hypertension, and age have the lowest impact on the determination of the subject's health status. The main application of this new technology is the adoption of smart solutions (e.g., a mobile app) to customize the stratification of patients admitted to emergency departments (ED)s after a syncope event. Indeed, the adoption of these smart solutions gives the opportunity to customize risk stratification according to the specific clinical case (i.e., the patient's health status) and the physician's decision-making process (i.e., the desired levels of sensitivity and specificity). Moreover, a decision-making process based on these smart solutions might ensure a more effective use of available resources, improving the management of syncope patients and reducing the cost of inappropriate treatment and hospitalization.

Purpose: Intraoperative fluorescence imaging (FI) is a promising technique that could potentially guide oncologic surgeons toward more radical resections and thus improve clinical outcome. Despite the increase in the number of clinical trials, fluorescent agents and imaging systems for intraoperative FI, a standardized approach for imaging system performance assessment and post-acquisition image analysis is currently unavailable., Procedures: We conducted a systematic, controlled comparison between two commercially available imaging systems using a novel calibration device for FI systems and various fluorescent agents. In addition, we analyzed fluorescence images from previous studies to evaluate signal-to-background ratio (SBR) and determinants of SBR., Results: Using the calibration device, imaging system performance could be quantified and compared, exposing relevant differences in sensitivity. Image analysis demonstrated a profound influence of background noise and the selection of the background on SBR., Conclusions: In this article, we suggest clear approaches for the quantification of imaging system performance assessment and post-acquisition image analysis, attempting to set new standards in the field of FI.

In patients consulting in the Emergency Department for chest pain, a HEART score ≤ 3 has been shown to rule out an acute coronary syndrome (ACS) with a low risk of major adverse cardiac event (MACE) occurrence. A negative CARE rule (≤ 1) that stands for the first four elements of the HEART score may have similar rule-out reliability without troponin assay requirement. We aim to prospectively assess the performance of the CARE rule and of the HEART score to predict MACE in a chest pain population. Prospective two-center non-interventional study. Patients admitted to the ED for non-traumatic chest pain were included, and followed-up at 6 weeks. The main study endpoint was the 6-week rate of MACE (myocardial infarction, coronary angioplasty, coronary bypass, and sudden unexplained death). 641 patients were included, of whom 9.5% presented a MACE at 6 weeks. The CARE rule was negative for 31.2% of patients, and none presented a MACE during follow-up [0, 95% confidence interval: (0.0-1.9)]. The HEART score was ≤ 3 for 63.0% of patients, and none presented a MACE during follow-up [0% (0.0-0.9)]. With an incidence below 2% in the negative group, the CARE rule seemed able to safely rule out a MACE without any biological test for one-third of patients with chest pain and the HEART score for another third with a single troponin assay.

Background: Discharge planning is an important component of hospital care. The Blaylock Risk Assessment Screening Score (BRASS) index is an instrument used to identify patients requiring complex discharge planning., Objectives: (1) Evaluate the ability of the original BRASS index to predict the risk of complex discharge and hospital mortality. (2) Develop and validate a simplified BRASS index by eliminating redundant variables and re-estimating the predictor weights., Design: Prospective cohort study., Participants: Patients admitted at the general internal medicine wards of tertiary referral hospital in Turin, Italy, and screened within 48 h using the BRASS index., Methods: The first phase of the study assessed the performance of the original BRASS index in predicting the risk of complex discharge and hospital mortality, then a simplified score was developed. In the second phase, temporal validation of the simplified BRASS index was performed. The probability of each discharge modality (discharged at home without complications, complex discharge, and dead in hospital) was modeled using polytomous logistic regression. The AUC was used to compare the performance of the different models., Key Results: Among 6044 patients in the first phase of the study, 63% were discharged at home without complications, 31% had complex discharge, and 6% died during the hospital stay. The AUC of the simplified BRASS index, compared with the original index were 0.71 vs. 0.70 for complex discharge and 0.83 vs. 0.80 for hospital mortality. In the validation set (3325 patients), the simplified BRASS index discriminates the outcome categories with an AUC of 0.69 and 0.81 for complex discharge and hospital mortality, respectively., Conclusion: The new, simplified BRASS index showed a slightly better performance in predicting the risk of complex discharge and hospital mortality than the original tool and takes less time to be applied. These results were also confirmed in the validation set.

Fracture probabilities resulting from the newly generated FRAX model for Belarus based on regional estimates of the hip fracture incidence were compared with FRAX models of neighboring countries. Differences between the country-specific FRAX patterns and the rank orders of fracture probabilities were modest., Objective: This paper describes the epidemiology of hip fractures in Belarus that was used to develop the country-specific fracture prediction FRAX® tool and illustrates its features compared to models for the neighboring countries of Poland, Russia, and Lithuania., Methods: We carried out a population-based study in a region of Belarus (the city of Mozyr) representing approximately 1.2% of the country's population. We aimed to identify all hip fractures in 2011-2012 from hospital registers and primary care sources. Age- and sex-specific incidence and national mortality rates were incorporated into a FRAX model for Belarus. Fracture probabilities were compared with those derived from FRAX models in neighboring countries., Results: The estimated number of hip fractures nationwide in persons over the age of 50 years for 2015 was 8250 in 2015 and is predicted to increase to 12,918 in 2050. The annual incidence of fragility hip fractures in individuals aged 50 years or more was 24.6/10,000 for women and 14.6/10,000 for men, standardized to the world population. The comparison with FRAX models in neighboring countries showed that hip fracture probabilities in men and women in Belarus were similar to those in Poland, Russia, and Lithuania. The difference in incidence rates between the surveys including or excluding data from primary care suggested that 29.1% of patients sustaining a hip fracture were not hospitalized and, therefore, did not receive specialized medical care., Conclusion: A substantial proportion of hip fractures in Belarus does not come to hospital attention. The FRAX model should enhance accuracy of determining fracture probability among the Belarus population and help guide decisions about treatment.

Several widely used scoring systems for septic patients have been validated in an ICU setting, and may not be appropriate for other settings like Emergency Departments (ED) or High-Dependency Units (HDU), where a relevant number of these patients are managed. The purpose of this study is to find reliable tools for prognostic assessment of septic patients managed in an ED-HDU. In 742 patients diagnosed with sepsis/severe sepsis/septic shock, not-intubated, admitted in ED between June 2008 and April 2016, SOFA, qSOFA, PIRO, MEWS, Charlson Comorbidity Index, MEDS, and APACHE II were calculated at ED admission (T0); SOFA and MEWS were also calculated after 24 h of ED-High-Dependency Unit stay (T1). Discrimination and incremental prognostic value of SOFA score over demographic data and parameters of sepsis severity were tested. Primary outcome is 28-day mortality. Twenty-eight day mortality rate is 31%. The different scores show a modest-to-moderate discrimination (T0 SOFA 0.695; T1 SOFA 0.741; qSOFA 0.625; T0 MEWS 0.662; T1 MEWS 0.729; PIRO: 0.646; APACHE II 0.756; Charlson Comorbidity Index 0.596; MEDS 0.674, all p < 0.001). At a multivariate stepwise Cox analysis, including age, Charlson Comorbidity Index, MEWS, and lactates, SOFA shows an incremental prognostic ability both at T0 (RR 1.165, IC 95% 1.009-1.224, p < 0.0001) and T1 (RR 1.168, IC 95% 1.104-1.234, p < 0.0001). SOFA score shows a moderate prognostic stratification ability, and demonstrates an incremental prognostic value over the previous medical conditions and clinical parameters in septic patients.

Patients with atrial fibrillation (AF) often undergo troponin (Tn) testing in the emergency department (ED), but the clinical significance of mildly elevated values remains unclear. We evaluated short-term 30-day post-discharge outcomes in AF patients according to troponin levels. Out of 2181 AF patients evaluated in the ED (June 2014 to June 2015), we included consecutive admitted patients. Patients were grouped into those with normal Tn values (≤ 0.05 ng/mL), mild elevations (> 0.05-0.5 ng/mL, 10× URL) and marked elevations (> 0.5 ng/mL). Outcomes included acute coronary syndrome (ACS), revascularization, all-cause mortality and combined end point; the secondary outcome was ischemic stroke. A total of 348 patients (90.9%) had Tn testing, which was associated with longer in-hospital stay (median 2.04 vs. 0.74 days in unmeasured Tn, p = 0.014); 37.1% did not have clinical suspicion of ACS. Mild Tn elevation occurred in 19.0% and 6.3% had markedly elevated values. Compared to normal values, mild elevations had higher absolute incidence, without statistical significance, of ACS (1.5 vs. 0.0%, p = 0.202), revascularization (1.5 vs. 0.0%, p = 0.202), all-cause mortality (12.1 vs. 6.9%, p = 0.200), combined end point (13.3 vs. 6.9%, p = 0.084) or ischemic stroke (4.5 vs. 2.3%, p = 0.394). Tn testing is routine in admitted AF patients, even without suspicion of ACS, and is associated with prolonged stay. Mild Tn elevation is associated with a nonsignificant trend toward higher adverse events. Larger-scale studies are needed to evaluate the cost-effectiveness of Tn testing for prognosis in admitted AF patients, as this prolongs stay and has unclear impact on patient management.

Acute variceal bleeding should be suspected in all patients with cirrhosis presenting with upper gastrointestinal bleeding. Vasoactive drugs and prophylactic antibiotics must be started as soon as possible, even before performing the diagnostic endoscopy. Once the patient is hemodynamically stable, upper gastrointestinal endoscopy should be performed in order to confirm the diagnosis and provide endoscopic therapy (preferably banding ligation). After this initial approach, the most appropriate therapy to prevent both early and late rebleeding must be instituted following a risk stratification strategy. The present chapter will focus on the initial management of patients with acute variceal bleeding, including general management and hemostatic therapies, as well as the available treatments in case of failure to control bleeding or development of rebleeding.

The UK has adopted a broader approach to the introduction of Environmental Quality Standard (EQS) for the aquatic environment than many other jurisdictions around the world, with a greater focus on the implementation of scientifically derived standards. This follows the publication of a report by the Royal Commission on Environmental Pollution in 1998 which drew attention to the need to recognise that whilst an EQS is often just viewed as a numerical value, it also has other important characteristics that need to be recognised if it is to be a practical and effective regulatory tool. One of the aspects that has not always been recognised was that of implementation assessment, i.e. the steps needed to ensure that a standard actually delivers environmental benefit or improvements. In many jurisdictions, there is considerable technical and sometimes political emphasis on the numerical value of the EQS (e.g. the critical concentration in an environmental matrix like water), including the method of derivation, the scrutiny of the reliability and relevance of the ecotoxicity test data and extensive deliberations of unquantified uncertainties in relation to the choice of assessment factor. The regulatory value of an EQS only comes through a comparison against a measured environmental concentration, yet only relatively limited regulatory effort has historically been expended on this component of the classic environmental risk assessment paradigm. For example, there needs to be an acceptable (i.e. small) uncertainty in the EQS, an appropriate analytical method and detection limit in the correct matrix, a method to deliver a comparison with the EQS and a robust statistical method to draw unbiased conclusions about environmental risk. In addition, we argue that there is a case for checking the consequences of introducing a standard against field data, wherever possible. This validation of the EQS rarely happens currently. We explain what implementation assessment is and why it is needed. We give examples of how implementation assessment can be integrated with EQS derivation and also present examples of what happens when the focus is only upon the derivation of a numerical value. It is clear from this evidence that advances in derivation methods need to be coupled with practical solutions of implementation if we are to realise environmental benefit from an EQS in a cost-effective manner.

Clinical risk factors for fracture in Southern Brazil are similar to those used in Fracture Risk Assessment Tool (FRAX®). Age-dependent intervention thresholds had higher accuracy than a fixed cut-off point., Introduction: Access to bone mineral density testing is wanted for a large part of the Brazilian population. The FRAX® has an option to calculate the risk of fracture without this costly evaluation but relies on the clinical risk factors (CRFs) identified in the source cohorts used to generate FRAX., Objective: The aims of this study were to determine whether the CRFs used in FRAX are also risk indicators for individuals in Southern Brazil and to evaluate possible intervention thresholds for treatment in Brazil., Methods: We determined the CRFs for hip fractures in women and men aged 50 years and more with a hip fracture and controls in Joinville, Southern Brazil (April 1, 2010, and March 31, 2012). For intervention thresholds, we determined the accuracy of using the fixed thresholds of National Osteoporosis Foundation (NOF), USA, compared with the age-dependent thresholds of the National Osteoporosis Guideline Group (NOGG), UK., Results: CRFs that were significant for hip fracture were very similar to FRAX, apart from chronic obstructive pulmonary disease and malabsorptive intestinal disease. FRAX based on the NOGG and NOF models had an accuracy of 64.2 and 58.7%, respectively., Conclusion: CRFs used in FRAX® were similar to those in the Southern Brazil. The NOGG model seems to be more accurate to discriminate patients with increased fracture risk in this population compared to the NOF model, but not significantly.

Our aims were to create and validate a clinical decision rule to assess severity in acute heart failure. We conducted a prospective cohort study of patients with symptoms of acute heart failure who attended the emergency departments (EDs) of three hospitals between April 2011 and April 2013. The following data were collected on arrival to or during the stay in the ED: baseline severity of symptoms; presence of decompensated comorbidities; number of hospital admissions/visits to EDs for acute heart failure during the previous 24 months; triggers of the exacerbation; clinical signs and symptoms; results of ancillary tests requested in the ED; treatments prescribed; and response to the initial treatment in the ED. The main outcome was poor course during the acute phase, in-hospital for admitted patients and during the first week following the ED visit for discharged patients, this being a composite endpoint that included death, admission to an intensive care unit, need for invasive mechanical ventilation, cardiac arrest and use of non-invasive mechanical ventilation. Multivariate logistic regression models were developed. Predictors of poor course in acute heart failure were oedema on chest radiography, visits to the ED and/or admissions in the previous two years, and levels of glycemia and blood urea nitrogen (areas under the curve of 0.83 in the derivation sample, and 0.82 in the validation sample). Four clinical predictors available in the ED can be used to create a simple score to predict poor course in acute heart failure.Clinical Trials.gov ID: NCT02437058.

Introduction: In 2008, the UK National Osteoporosis Guideline Group (NOGG) produced a guideline on the prevention and treatment of osteoporosis, with an update in 2013. This paper presents a major update of the guideline, the scope of which is to review the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women and men age 50 years or over., Methods: Where available, systematic reviews, meta-analyses and randomised controlled trials were used to provide the evidence base. Conclusions and recommendations were systematically graded according to the strength of the available evidence., Results: Review of the evidence and recommendations are provided for the diagnosis of osteoporosis, fracture-risk assessment, lifestyle measures and pharmacological interventions, duration and monitoring of bisphosphonate therapy, glucocorticoid-induced osteoporosis, osteoporosis in men, postfracture care and intervention thresholds., Conclusion: The guideline, which has received accreditation from the National Institute of Health and Care Excellence (NICE), provides a comprehensive overview of the assessment and management of osteoporosis for all healthcare professionals who are involved in its management.

Screening in a standardized manner for osteoporosis in non-vertebral fracture patients aged 50 and older independently of both gender and level of trauma energy yielded the indication for osteoporotic therapy for every fourth male high-energy fracture patient., Purpose: This study aimed to identify the rate of osteoporosis in patients of both genders after fracture independently of the underlying level of trauma energy., Methods: A random cohort of patients aged 50 or older with non-vertebral fractures participated in a standardized diagnostic protocol to evaluate the indication for treatment of osteoporosis (number needed to screen (NNS)). Univariate and multivariate analysis as well as correlation testing were performed to determine statistical relationships. Significance was set at p < 0.05., Results: Of 478 fracture patients with a mean age of 69.3 ± 11.8 years, 317 (66.3%) were female and 161 (33.7%) male. One hundred nineteen patients (24.9%) sustained high-energy fractures (HEFs) and 359 (75.1%) low-energy fractures (LEFs). Twenty-eight percent of males and 47% of females qualified as osteoporotic in densitometry (dual-energy X-ray absorptiometry (DXA)), resulting in a NNS of 2.1 for women and 3.6 for men. The indication for treatment of osteoporosis increased to an NNS of 1.5 for females and 2.4 for males if the fracture risk assessment tool (FRAX) was included in the diagnostics (DXA and FRAX). With regard to the energy of trauma, the NNS for treatment following DXA and FRAX was 1.5 for LEF and 2.9 for HEF. Subgroup analysis revealed that HEF males within the decennia 50+ and 80+ had an NNS of around 3, i.e., comparable to females and about twice as high as LEF patients., Conclusions: These preliminary findings appear to confirm the pragmatic approach to screening in a standardized manner for osteoporosis in all non-vertebral fracture patients aged 50 and older-independently of both gender and level of trauma energy.

The In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) rule can accurately identify pulmonary embolism (PE) patients at low risk of early complications using claims data. We sought to externally validate the IMPACT and simplified Pulmonary Embolism Severity Index (sPESI) tools for predicting all-cause mortality and readmission. We used Veteran Health Administration data (10/1/2010-9/30/2015) to identify adults with ≥1 inpatient diagnosis code for acute PE, ≥12 months continuous medical and pharmacy benefits prior to the index PE, ≥90 days of post-event follow-up (unless death occurred) and ≥1 claim for an anticoagulant during the index PE stay. Prognostic accuracies of IMPACT and sPESI for 30- and 90-day all-cause mortality and 90-day readmission were estimated. Of 6,746 PE patients, 7.5 and 12.6% died at 30 and 90 days. Within 90 days, 20.1% were readmitted for any reason. Hospitalization for recurrent VTE and major bleeding occurred in 5.6 and 1.7% of patients. IMPACT classified 15.2% as low risk, while 28.4% were low risk per sPESI. Both tools displayed sensitivity >90% and negative predictive values (NPVs) >97% for 30-day mortality, but low specificity (range 16.2-30.0) and positive predictive values (PPVs) (range 8.7-9.5); with similar results observed for 90-day mortality. IMPACT's sensitivity for all-cause readmission was numerically higher than sPESI (88.2 vs. 79.0%), but both had comparable NPVs (85.1 vs. 84.2%). Similar trends were observed for VTE or major bleeding readmissions. IMPACT classified patients for post-PE outcomes with similar accuracy as sPESI. IMPACT appears useful for identifying PE patients at low risk for early mortality or readmission in claims-based studies.

Few studies to date address the predictive ability of CHA 2 DS 2 -VASc and R 2 CHADS 2 in CAD patients. Our aim is to investigate the prognostic performance of CHADS 2 , CHA 2 DS 2 -VASc and R 2 CHADS 2 scores in patients with coronary artery disease (CAD). Angiographically obstructive CAD patients were enrolled. The prognostic performance of the three risk scores was evaluated using Cox hazards models. In addition, we compared their predictive values by calculating C statistics, net reclassification improvement (NRI) and integrated discrimination improvement (IDI). The endpoints are death from any cause and cardiovascular death. Of 3295 subjects with CAD, the mean CHADS 2 , CHA 2 DS 2 -VASc and R 2 CHADS 2 scores are 1.2 ± 1.0, 2.4 ± 1.4, and 1.6 ± 1.4, respectively. The CHADS 2 -guided risk classification is markedly distinct from CHA 2 DS- 2 -VASc- and R 2 CHADS 2 -guided ones. Over a median follow-up of 24 months, a total of 290 (rate 4.00/100 person-year) deaths occurred, and 163 (rate 2.2/100 person-year) were attributed to cardiovascular deaths. Event rates increase by CHADS 2 , CHA 2 DS 2 -VASc and R 2 CHADS 2 (P for trend <0.001). The multivariate analyses show 60, 111 and 82% higher risk of mortality per unit increase of CHADS 2 , CHA 2 DS 2 -VASc and R 2 CHADS 2 scores, respectively. Comparing with CHADS 2 score (c-statistic = 0.61), CHA 2 DS 2 -VASc (c-statistic 0.65, NRI 0.52 and IDI 0.06, P for all <0.05) and R 2 CHADS 2 (c-statistic 0.66, NRI 0.43 and IDI 0.09, P for all <0.05) scores provide better discrimination and reclassification for mortality. Also, CHA 2 DS 2 -VASc and R 2 CHADS 2 have comparable predictive ability of mortality to the GRACE score. The CHADS 2 , CHA 2 DS 2 -VASc and R 2 CHADS 2 scores are simple yet robust prognostic tools in CAD patients.

In patients with systemic sclerosis, a ratio between forced vital capacity (FVC) and diffusing capacity of carbon monoxide (DLCO, FCV%/DLCO%) >1.5 might be a predictor of pulmonary hypertension (PH). The aim of this study is, therefore, to evaluate whether this index can be used in patients with PH, regardless of etiology. 83 consecutive outpatients with suspected PH at non-invasive work-up underwent spirometry and DLCO test before right heart catheterization (RHC); FVC%/DLCO% ratio was then calculated and compared with mean pulmonary-artery-pressure (mPAP) and mortality at 5-year follow-up. Significant correlations between FVC%/DLCO% and PAsP and mPAP levels were found (p < 0.05). After ROC curve analysis and definition of best cut-off values for PAsP and FVC%/DLCO%, increased mPAP values at RHC were observed comparing subjects with both PAsP and FVC%/DLCO% values below cut off values (-/-), either PAsP or FVC%/DLCO% above cut off values (±), or both above (+/+) (p < 0.05). Poorer survival rates are observed at follow-up with higher FVC%/DLCO% values (0% for <1, 17.4% for 1-3, 33.3% for >3, p < 0.05), when comparing subjects with either increased PAsP and FVC%/DLCO% values or both with those with lower (log-rank p < 0.05). Even in subjects with mPAP at RHC >25 mmHg, increased FVC%/DLCO% values predicted a worse outcome (p < 0.05). FVC%/DLCO% values are related to mPAP in subjects with suspected PH, and may further stratify the risk of mortality in addition to PAP.

The HEART score is a simple scoring system, ranging from 0 to 10, specifically developed for risk stratification of patients with undifferentiated chest pain. It has been validated for the conventional troponin, but not for high-sensitive troponin. We assess a modified version of the HEART score using a single high-sensitivity troponin T dosage at presentation, regardless of symptom duration, and with different ECG criteria to evaluate if the patients with a low HEART score could be safely discharged early. The secondary aim was to confirm a statistically significant difference in each HEART score group (low 0-3, intermediate 4-6, high 7-10) in the occurrence of major adverse cardiac events at 30 and 180 days. We retrospectively analyzed the HEART score of 1597 consecutive patients admitted to the Emergency Department of our Hospital for chest pain between January 1 and June 30, 2014. Of these, 190 did not meet the inclusion criteria and 29 were lost to follow-up. None of the 512 (37.2 %) patients with a low HEART score had an event within 180 days. The difference between the cumulative incidences of events in the three HEART score groups was statistically significant (P < 0.0001). We demonstrate that it might be possible to safely discharge Emergency Department chest pain patients with a low modified HEART score after an initial determination of high-sensitive troponin T, without a prolonged observation period or an additional cardiac testing.

The presence of major depressive symptoms is usually considered a negative long-term prognostic factor after an acute myocardial infarction (AMI); however, most of the supporting research was conducted before the era of immediate reperfusion by percutaneous coronary intervention. The aims of this study are to evaluate if depression still retains long-term prognostic significance in our era of immediate coronary reperfusion, and to study possible correlations with clinical parameters of physical performance. In 184 patients with recent ST-elevated AMI (STEMI), treated by immediate reperfusion, moderate or severe depressive symptoms (evaluated by Beck Depression Inventory version I) were present in 10 % of cases. Physical performance was evaluated by two 6-min walk tests and by a symptom-limited cardiopulmonary exercise test: somatic/affective (but not cognitive/affective) symptoms of depression and perceived quality of life (evaluated by the EuroQoL questionnaire) are worse in patients with lower levels of physical performance. Follow-up was performed after a median of 29 months by means of telephone interviews; 32 major adverse cardiovascular events (MACE) occurred. The presence of three vessels disease and low left ventricle ejection fraction are correlated with a greater incidence of MACE; only somatic/affective (but not cognitive/affective) symptoms of depression correlate with long-term outcomes. In patients with recent STEMI treated by immediate reperfusion, somatic/affective but not cognitive/affective symptoms of depression show prognostic value on long-term MACE. Depression symptoms are not predictors "per se" of adverse prognosis, but seem to express an underlying worse cardiac efficiency, clinically reflected by poorer physical performance.

Amyloidosis prognosis is often related to the onset of heart failure and a worsening that is concomitant with kidney-liver dysfunction; thus the Model for End-stage Liver disease (MELD) may be an ideal instrument to summarize renal-liver function. Our aim has been to test the MELD score as a prognostic tool in amyloidosis. We evaluated 128 patients, 46 with TTR-related amyloidosis and 82 with AL amyloidosis. All patients had a complete clinical and echocardiography evaluation; overall biohumoral assessment included troponin I, NT-proBNP, creatinine, total bilirubin and INR ratio. The study population was dichotomized at the 12 cut-off level of MELD scores; those with MELD score >12 had a lower survival compared to controls in the study cohort (40.7 vs 66.3 %; p = 0.006). Either as a continuous and dichotomized variable, MELD shows its independent prognostic value at multivariable analysis (HR = 1.199, 95 % CI 1.082-1.329; HR = 2.707, 95 % CI 1.075-6.817, respectively). MELD shows a lower prognostic sensitivity/specificity ratio than troponin I and NT-proBNP in the whole study population and AL subgroup, while in TTR patients MELD has a higher sensitivity/specificity ratio compared to troponin and NT-proBNP (ROC analysis-AUC: 0.853 vs 0.726 vs 0.659). MELD is able to predict prognosis in amyloidosis. A MELD score >12 selects a subgroup of patients with a higher risk of death. The predictive accuracy seems to be more evident in TTR patients in whom currently no effective scoring systems have been validated.

Pollen information as such is highly valuable and was considered so far as a self-evident good free for the public. The foundation for reliable and serious pollen information is the careful, scientific evaluation of pollen content in the air. However, it is essential to state and define now the requirements for pollen data and qualifications needed for institutions working with pollen data in the light of technical developments such as automated pollen counting and various political interests in aerobiology including attempts to finally acknowledge pollen and spores as relevant biological particles in the air worth being considered for pollution and health directives. It has to be emphasized that inadequate pollen forecasts are a considerable health risk for pollen allergy sufferers. Therefore, the responsibility of institutions involved in pollen monitoring and forecasting is high and should be substantiated with respective qualifications and know-how. We suggest here for the first time a portfolio of quality criteria and demand rigorous scientific monitoring and certification of such institutions in the interest and for the protection of persons affected by a pollen allergy.

Unlabelled: This systematic review identified assessment guidelines for osteoporosis that incorporate FRAX. The rationale for intervention thresholds is given in a minority of papers. Intervention thresholds (fixed or age-dependent) need to be country-specific., Introduction: In most assessment guidelines, treatment for osteoporosis is recommended in individuals with prior fragility fractures, especially fractures at spine and hip. However, for those without prior fractures, the intervention thresholds can be derived using different methods. The aim of this report was to undertake a systematic review of the available information on the use of FRAX® in assessment guidelines, in particular the setting of thresholds and their validation., Methods: We identified 120 guidelines or academic papers that incorporated FRAX of which 38 provided no clear statement on how the fracture probabilities derived are to be used in decision-making in clinical practice. The remainder recommended a fixed intervention threshold (n = 58), most commonly as a component of more complex guidance (e.g. bone mineral density (BMD) thresholds) or an age-dependent threshold (n = 22). Two guidelines have adopted both age-dependent and fixed thresholds., Results: Fixed probability thresholds have ranged from 4 to 20 % for a major fracture and 1.3-5 % for hip fracture. More than one half (39) of the 58 publications identified utilised a threshold probability of 20 % for a major osteoporotic fracture, many of which also mention a hip fracture probability of 3 % as an alternative intervention threshold. In nearly all instances, no rationale is provided other than that this was the threshold used by the National Osteoporosis Foundation of the USA. Where undertaken, fixed probability thresholds have been determined from tests of discrimination (Hong Kong), health economic assessment (USA, Switzerland), to match the prevalence of osteoporosis (China) or to align with pre-existing guidelines or reimbursement criteria (Japan, Poland). Age-dependent intervention thresholds, first developed by the National Osteoporosis Guideline Group (NOGG), are based on the rationale that if a woman with a prior fragility fracture is eligible for treatment, then, at any given age, a man or woman with the same fracture probability but in the absence of a previous fracture (i.e. at the 'fracture threshold') should also be eligible. Under current NOGG guidelines, based on age-dependent probability thresholds, inequalities in access to therapy arise especially at older ages (≥70 years) depending on the presence or absence of a prior fracture. An alternative threshold using a hybrid model reduces this disparity., Conclusion: The use of FRAX (fixed or age-dependent thresholds) as the gateway to assessment identifies individuals at high risk more effectively than the use of BMD. However, the setting of intervention thresholds needs to be country-specific.

Not all patients with upper gastrointestinal bleeding (UGIB) require emergency endoscopy. Lactate clearance has been suggested as a parameter for predicting patient outcomes in various critical care settings. This study investigates whether lactate clearance can predict active bleeding in critically ill patients with UGIB. This single-center, retrospective, observational study included critically ill patients with UGIB who met all of the following criteria: admission to the emergency department (ED) from April 2011 to August 2014; had blood samples for lactate evaluation at least twice during the ED stay; and had emergency endoscopy within 6 h of ED presentation. The main outcome was active bleeding detected with emergency endoscopy. Classification and regression tree (CART) analyses were performed using variables associated with active bleeding to derive a prediction rule for active bleeding in critically ill UGIB patients. A total of 154 patients with UGIB were analyzed, and 31.2 % (48/154) had active bleeding. In the univariate analysis, lactate clearance was significantly lower in patients with active bleeding than in those without active bleeding (13 vs. 29 %, P < 0.001). Using the CART analysis, a prediction rule for active bleeding is derived, and includes three variables: lactate clearance; platelet count; and systolic blood pressure at ED presentation. The rule has 97.9 % (95 % CI 90.2-99.6 %) sensitivity with 32.1 % (28.6-32.9 %) specificity. Lactate clearance may be associated with active bleeding in critically ill patients with UGIB, and may be clinically useful as a component of a prediction rule for active bleeding.

Health risk assessments generally involve many extrapolations: for example, from animals to humans or from high doses to lower doses. Health risk assessments for PCBs involve all the usual uncertainties, plus additional uncertainties due to the nature of PCBs as a dynamic, complex mixture. Environmental processes alter PCB mixtures after release into the environment, so that people are exposed to mixtures that might not resemble the mixtures where there are toxicity data. This paper discusses the evolution of understanding in assessments of the cancer and noncancer effects of PCBs. It identifies where a lack of data in the past contributed to significant uncertainty and where new data subsequently altered the prevailing understanding of the toxicity of PCB mixtures, either qualitatively or quantitatively. Finally, the paper identifies some uncertainties remaining for current PCB health assessments, particularly those that result from a lack of data on exposure through nursing or on effects from inhalation of PCBs.

Vaccines are among the most effective preventive measures in modern medicine and have led to a dramatic decline and-for a few diseases-even to the elimination of severely infectious diseases. There are some particularities of the risk-benefit assessment of vaccines compared with that of therapeutic drugs. These include the fact that vaccines are applied to healthy individuals with the aim of preventing an infectious disease, while therapeutic drugs are administered to sick people to cure them of an already acquired disease. The acceptable level of risk associated with the application of a vaccine is therefore much lower. In addition, high vaccination coverage can lead to population-level effects (e.g., the indirect protection of unvaccinated individuals) that can confer additional benefits to the population overall. When a marketing authorization application (MAA) for a novel vaccine is evaluated, conclusions are made regarding its quality, safety, and efficacy, and a benefit-risk assessment is carried out accordingly. In contrast, when deciding on the introduction of a new vaccine into a national immunization program or on a recommendation for a specific risk-group, the focus is shifted to considerations of how a licensed vaccine can be best used in a population (e.g., which immunization strategy is most effective in preventing deaths or hospitalizations, or in reducing treatment costs for the health care system). Stringent assessment criteria have been developed that require a robust safety analysis before a new vaccine is administered to humans for the first time in pre-licensure studies. Similarly, criteria are applied for calculating the benefit-risk ratio at the time of the licensure of a new vaccine in addition to during the entire post-licensure period. However, when deciding if and how a licensed vaccine can best be integrated into an existing immunization program, additional criteria are applied that are different, yet complementary to those applied for granting a marketing authorization. These decisions require-in addition to considerations of vaccine quality, vaccine efficacy and safety-conclusions regarding population-level effects combined with an integrative analysis of the local context (e.g., local epidemiology, cost-effectiveness, and acceptance by the population). To serve these objectives, national authorities such as the Standing Committee on Vaccination in Germany (STIKO) have been established to integrate globally developed vaccines into the national context of immunization strategies.

Unlabelled: The Brazilian FRAX model is described and used to determine intervention thresholds for the treatment of osteoporosis., Introduction: A FRAX model for Brazil was released May 1, 2013. This paper describes the data used to develop the Brazilian FRAX(®) model, illustrates its features and develops intervention thresholds., Methods: Age- and sex-stratified hip fracture incidence rates were extracted from four regional estimates from the age of 40 years. For other major fractures, Brazilian incidence rates were estimated using Swedish ratios for hip to other major osteoporotic fracture (humerus, forearm or clinical vertebral fractures). Assessment and intervention thresholds were determined using the approach recommended by the National Osteoporosis Guideline Group (UK) applied to the Brazilian FRAX model., Results: Fracture incidence rates increased with increasing age: for hip fracture, incidence rates were higher amongst younger men than women but with a female preponderance from the age of 50 years. Ten-year probability of hip or major fracture was increased in patients with a clinical risk factor, lower BMI, female gender, a higher age and a decreased BMD T-score. Of the clinical risk factors, prior fracture accounted for the greatest increase in 10-year fracture probability at younger ages while a parental hip fracture history was the strongest risk factor at ages 80-90 years. Age-dependent probability-based intervention thresholds were developed equivalent to women with a prior fragility fracture., Conclusions: The FRAX tool is the first to provide a country-specific fracture prediction model for Brazil. It is based on the original FRAX methodology, which has been externally validated in several independent cohorts. Despite some limitations, the strengths make the Brazilian FRAX tool a good candidate for implementation into clinical practice.

Systemic error analysis plays a key role in clinical risk management. This includes all clinical and administrative activities which identify, assess and reduce the risks of damage to patients and to the organization. The clinical risk management is an integral part of quality management. This is also the policy of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) on the fundamental requirements of an internal quality management. The goal of all activities is to improve the quality of medical treatment and patient safety. Primarily this is done by a systemic analysis of incidents and errors. A results-oriented systemic error analysis needs an open and unprejudiced corporate culture. Errors have to be transparent and measures to improve processes have to be taken. Disciplinary action on staff must not be part of the process. If these targets are met, errors and incidents can be analyzed and the process can create added value to the organization. There are some proven instruments to achieve that. This paper discusses in detail the error and risk analysis (ERA), which is frequently used in German healthcare organizations. The ERA goes far beyond the detection of problems due to faulty procedures. It focuses on the analysis of the following contributory factors: patient factors, task and process factors, individual factors, team factors, occupational and environmental factors, psychological factors, organizational and management factors and institutional context. Organizations can only learn from mistakes by analyzing these factors systemically and developing appropriate corrective actions. This article describes the fundamentals and implementation of the method at the University Medical Center Hamburg-Eppendorf.

Unlabelled: We have validated our touch-screen-modified FRAX® tool against the traditional healthcare professional-led questionnaire, demonstrating strong concordance between doctor- and patient-derived results. We will use this in outpatient clinics and general practice to increase our capture rate of at-risk patients, making valuable use of otherwise wasted patient waiting times., Introduction: Outpatient clinics offer an opportunity to collect valuable health information from a captive population. We have previously developed a modified fracture risk assessment (FRAX®) tool, enabling patients to self-assess their osteoporotic fracture risk in a touch-screen computer format and demonstrated its acceptability with patients. We aim to validate the accuracy of our tool against the traditional questionnaire., Methods: Fifty patients over 50 years of age within the fracture clinic independently completed a paper equivalent of our touch-screen-modified FRAX® questionnaire. Responses were analysed against the traditional healthcare professional (HCP)-led questionnaire which was carried out afterwards. Correlation was assessed by sensitivity, specificity, Cohen's kappa statistic and Fisher's exact test for each potential FRAX® outcome of "treat", "measure BMD" and "lifestyle advice"., Results: Age range was 51-98 years. The FRAX® tool was completed by 88 % of patients; six patients lacked confidence in estimating either their height or weight. Following question adjustment according to patient response and feedback, our tool achieved >95 % sensitivity and specificity for the "treat" and "lifestyle advice" groups, and 79 % sensitivity and 100 % specificity in the "measure BMD" group. Cohen's kappa value ranged from 0.823 to 0.995 across all groups, demonstrating "very good" agreement for all. Fisher's exact test demonstrated significant concordance between doctor and patient decisions., Discussion: Our modified tool provides a simple, accurate and reliable method for patients to self-report their own FRAX® score outside the clinical contact period, thus releasing the HCP from the time required to complete the questionnaire and potentially increasing our capture rate of at-risk patients.

Objective: The current paper aims to: (1) examine clinical practice guidelines in suicide prevention across fields, organizations, and clinical specialties and (2) inform emerging standards in clinical practice, research, and training., Methods: The authors conducted a systematic literature review to identify clinical practice guidelines and resource documents in suicide prevention and risk management. The authors used PubMed, Google Scholar, and Google Search, and keywords included: clinical practice guideline, practice guideline, practice parameters, suicide, suicidality, suicidal behaviors, assessment, and management. To assess for commonalities, the authors reviewed guidelines and resource documents across 13 key content categories and assessed whether each document suggested validated assessment measures., Results: The search generated 101 source documents, which included N = 10 clinical practice guidelines and N = 12 additional resource documents (e.g., non-formalized guidelines, tool-kits). All guidelines (100 %) provided detailed recommendations for the use of evidence-based risk factors and protective factors, 80 % provided brief (but not detailed) recommendations for the assessment of suicidal intent, and 70 % recommended risk management strategies. By comparison, only 30 % discussed standardization of risk-level categorizations and other content areas considered central to best practices in suicide prevention (e.g., restricting access to means, ethical considerations, confidentiality/legal issues, training, and postvention practices). Resource documents were largely consistent with these findings., Conclusions: Current guidelines address similar aspects of suicide risk assessment and management, but significant discrepancies exist. A lack of consensus was evident in recommendations across core competencies, which may be improved by increased standardization in practice and training. Additional resources appear useful for supplemental use.